Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients

Abstract

This study aimed to investigate the efficacy and safety of drug-eluting beads (DEB) transarterial chemoembolization (TACE) treatment in Chinese intrahepatic cholangiocarcinoma (ICC) patients. 37 ICC patients underwent DEB-TACE treatment in CTILC study (registered on clinicaltrials.gov with registry No. NCT03317483) were included in this present study. Treatment response was assessed according to modified Response Evaluation Criteria in Solid Tumors (mRECIST). Overall survival (OS) was calculated from the time of DEB-TACE operation until the date of death from any causes. Liver function change and adverse events (AEs) were recorded during and after DEB-TACE operation. 3 (8.1%) patients achieved complete response (CR) and 22 (59.5%) patients achieved partial response (PR), with objective response rate (ORR) of 67.6%. After DEB-TACE treatment, mean OS was 376 days (95%CI: 341–412 days). Multivariate logistic regression analysis revealed that Bilobar disease (P = .040, OR: 0.105, 95% CI: 0.012–0.898) and portal vein invasion (P = .038, OR: 0.104, 95% CI: 0.012–0.881) could independently predict less possibility of ORR. Patients with ALB abnormal, TP abnormal, ALT abnormal and AST abnormal were increased at 1-week post DEB-TACE treatment (P = .034, P = .001, P < .001, P = .006, respectively), while returned to the levels at baseline after 1 to 3 months (all P > .050). Besides, most of the AEs were mild including pain, fever, vomiting, and nausea in this study. DEB-TACE was effective and well tolerated in treating ICC patients, and bilobar disease as well as portal vein invasion were independently correlated with less probability of ORR achievement.

A comparative study of efficacy and safety of transarterial chemoembolization with CalliSpheres and conventional transarterial chemoembolization in treating unresectable intrahepatic cholangiocarcinoma patients

“…It is reported that DEB-TACE with Callispheres microsphere increases tumor response featured by higher ORR and CR rates compared to cTACE in HCC patients [9,10]. Regarding its clinical application in ICC patients, two single-armed retrospective studies show that the ORR rates in DEB-TACE with Callispheres microsphere treated ICC patients are 65.9% and 67.6%, respectively [12,13]. Since DEB-TACE with Callispheres microsphere displays improved efficacy and safe compared to cTACE in treating HCC patients, also DEB-TACE with Callispheres microsphere is safe and well-tolerant in ICC patients, therefore we hypothesized that DEB-TACE with Callispheres microsphere might achieve great efficacy compared to cTACE in ICC patients.…”

“…In terms of the safety profile of DEB-TACE with Callispheres microsphere in ICC patients, one study discovers that the major adverse events of DEB-TACE with Callispheres microsphere in ICC patients are abdominal pain, fever, vomiting and nausea, which are all mild and manageable [12]. Among these, patients received DEB-TACE significantly less likely to experience abdominal pain compared to patients received cTACE.…”

“…In terms of its clinical application, DEB-TACE with CalliSpheres microsphere has formerly been applied in treating hepatocellular carcinoma (HCC) patients and gained promising efficacy with less safety issues compared to cTACE [9,10,11]. Furthermore, DEB-TACE with CalliSpheres microsphere also displays efficacy and safety in treating ICC patients [12,13]. However, to our best knowledge, no comparison between DEB-TACE using CalliSpheres microsphere and cTACE has been conducted in patients with unresectable ICC yet.…”

Impact of aging on primary liver cancer: epidemiology, pathogenesis and therapeutics

“…It has been demonstrated that TACE reaches satisfactory efficacy and is well tolerated in elderly patients, including those above 85 years old [ 114 , 115 ]. Recent studies have described that drug-eluting bead-TACE therapy was safe and effective in elderly patients either with HCC [ 116 ] or iCCA [ 117 ].…”

Interventional Treatment for Cholangiocarcinoma

“…Propensity score‐matched analysis showed a significant survival benefit for patients who received chemotherapy plus DEB-TACE compared to those undergoing chemotherapy only. Recently, a prospective multicenter study including 37 patients with iCCA was conducted ( 57 ). For patients treated with DEB-TACE loaded with Adriamycin, about 8.1% of them achieved CR, while 59.5% achieved PR.…”